[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Rules and Regulations]
[Pages 42571-42583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16207]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 194
[FRL-7787-6]
RIN 2060-AJ07
Criteria for the Certification and Recertification of the Waste
Isolation Pilot Plant's Compliance With the Disposal Regulations;
Alternative Provisions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (``EPA'' or ``the Agency''
or ``we'') is finalizing changes to the ``Criteria for the
Certification and Recertification of the Waste Isolation Pilot Plant's
Compliance with the Disposal Regulations,'' (``Compliance Criteria'')
proposed August 9, 2002 (67 FR 51930-51946). Today, after considering
public comments received in response to the proposed changes, we
finalize the following actions: Addition of a mechanism to address
minor changes to the provisions of the Compliance Criteria; changes to
the approval process for waste characterization programs at Department
of Energy (DOE) transuranic (TRU) waste sites; changes to the number of
copies of compliance applications and reference materials submitted to
EPA; and replacement of the term ``process knowledge'' with
``acceptable knowledge.'' Today's action will maintain or improve our
oversight at WIPP to ensure safe disposal of waste. Moreover, these
changes do not modify the technical approach that EPA employs when
conducting independent inspections of the waste characterization
capabilities at DOE waste generator/storage sites. EPA is conducting
this action in accordance with the procedures for substituting
alternative provisions in the Compliance Criteria.
DATES: This final rule is effective October 14, 2004.
FOR FURTHER INFORMATION CONTACT: Ray Lee; telephone number: (202) 343-
9463; postal address: Radiation Protection Division, Mail Code 6608J,
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460.
SUPPLEMENTARY INFORMATION:
I. General Information
A. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OAR-2002-0005. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at:
Air and Radiation Docket and Information Center, Room B-108, U.S.
Environmental Protection Agency, 301 Constitution Ave., NW.,
Washington, DC. This Docket Facility is open from 8:30 a.m.-4:30 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is (202) 566-1742.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments,
access the index listing of the contents of the official public docket,
and to access those documents in the public docket that are available
electronically. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
Once in the system, select ``search,'' then key in the appropriate
docket identification number (OAR-2002-0005 for this action).
Abbreviations Used in This Document
AK--Acceptable Knowledge
ANL-E--Argonne National Laboratory-East
APA--Administrative Procedure Act
BID--Background Information Document
CBFO--Carlsbad Field Office
CFR--Code of Federal Regulations
CH--Contact Handled
DOE--Department of Energy
EPA--Environmental Protection Agency
INEEL--Idaho National Energy and Engineering Laboratory
LANL--Los Alamos National Laboratory
NDA--Nondestructive Assay
NPRM--Notice of Proposed Rulemaking
NRC--Nuclear Regulatory Commission
NTS--Nevada Test Site
ORNL--Oak Ridge National Laboratory
PK--Process knowledge
RFETS--Rocky Flats Environmental Technology Site
RTR--Real-time radiography
SRS--Savannah River Site
TRU--Transuranic
VE--Visual inspection
WC--Waste characterization
WIPP--Waste Isolation Pilot Plant
WIPP LWA--WIPP Land Withdrawal Act
WWIS--WIPP Waste Information System
Table of Contents
I. What is the WIPP?
II. What changes did EPA propose?
A. Proposed changes to Sec. 194.6--process for adding minor
alternative provisions
B. Proposed changes to Sec. 194.8(b)--waste generator site
inspection and approval process
C. Proposed changes to Sec. Sec. 194.12 and 194.13--number and
form of DOE compliance applications and reference materials
D. Proposed changes to Sec. Sec. 194.2 and 194.24(c)(3)--
terminology related to waste characterization
III. What is EPA's final action in consideration of public comments?
A. Summary of comments and final changes to Sec. 194.6--process
for adding minor alternative provisions
B. Summary of comments and Final changes to Sec. 194.8(b)--
waste generator site inspection and approval process
C. Summary of comments and final changes to Sec. Sec. 194.12
and 194.13--number and form of DOE compliance applications and
reference materials
D. Summary of comments and final changes to Sec. Sec. 194.2 and
194.24(c)(3)--terminology related to waste characterization
IV. Statutory and Executive Order Reviews
A. Executive Order 12866
B. Congressional Review Act
C. Regulatory Flexibility Act
D. Paperwork Reduction Act
E. Unfunded Mandates Reform Act
F. Executive Order 12898
G. National Technology Transfer & Advancement Act of 1995
H. Executive Order 13045: Children's Health Protection
[[Page 42572]]
I. Executive Order 13132: Federalism
J. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
K. Executive Order 13211: Energy Effects
I. What Is the WIPP?
The Waste Isolation Pilot Plant (``WIPP'') is a disposal system for
transuranic (TRU) radioactive waste. Developed by the Department of
Energy (``DOE'' or ``the Department''), the WIPP is located near
Carlsbad in southeastern New Mexico. TRU waste is emplaced 2,150 feet
underground in an ancient layer of salt that will eventually ``creep''
and encapsulate the waste containers. The WIPP has a total capacity of
6.2 million cubic feet of TRU waste. Most TRU waste proposed for
disposal at WIPP consists of items that have become contaminated as a
result of activities associated with the production of nuclear weapons
(or with the cleanup of nuclear weapons production facilities), such
as, rags, equipment, tools, protective gear, and sludges. Some TRU
waste is contaminated with hazardous wastes regulated under the
Resource Conservation and Recovery Act (42 U.S.C. 6901-6992k)
(``RCRA''). The waste proposed for disposal at WIPP is currently stored
at Federal facilities across the United States, including locations in
Colorado, Idaho, New Mexico, Nevada, Ohio, South Carolina, Tennessee,
and Washington.
The WIPP must meet EPA's generic disposal standards at 40 CFR part
191 for high-level and TRU radioactive waste. These standards establish
numeric limits to ensure that the WIPP effectively contains radioactive
waste. To determine whether the WIPP performs well enough to meet these
disposal standards, EPA issued the WIPP Compliance Criteria (40 CFR
part 194) in 1997. The Compliance Criteria interpret and implement the
disposal standards specifically for the WIPP site. They describe what
information DOE must provide, how EPA evaluates the WIPP's performance,
and provides ongoing independent oversight.
Using the process outlined in the WIPP Compliance Criteria, EPA
determined on May 18, 1998, that DOE had demonstrated that the WIPP
complied with EPA's radioactive waste disposal regulations at subparts
B and C of 40 CFR part 191. EPA's certification determination permitted
the WIPP to begin accepting transuranic waste for disposal, provided
that other applicable environmental regulations were met. Also, the
disposal of TRU waste at WIPP is conditioned on the EPA determination
that activities conducted at waste generator sites appropriately comply
with the quality assurance (QA) and waste characterization (WC)
requirements established at Sec. 194.22 and Sec. 194.24,
respectively. (For a detailed discussion on all of the proposed
changes, see 67 FR 51930-51946; August 9, 2002.)
II. What Changes Did EPA Propose?
On August 9, 2002, EPA proposed to revise certain provisions of the
Compliance Criteria at 40 CFR part 194. Specifically, EPA proposed to
revise the following: (1) Process for establishing ``alternative
provisions'' in Sec. 194.6; (2) approval process in Sec. 194.8 for
waste characterization processes at TRU waste generator/storage sites
used to characterize TRU waste prior to its disposal at WIPP; (3)
requirements in Sec. Sec. 194.12 and 194.13 for submission of
compliance applications and reference material; and (4) replace the
term ``process knowledge'' with ``acceptable knowledge'' in Sec. Sec.
194.2 and 194.24(c)(3). The proposed revisions intend to ensure that 40
CFR part 194 remains comprehensive, appropriate, and is based upon
current knowledge and information. The Agency solicited comments on
this proposal over a period of 120 days. In addition, in September
2002, EPA held public hearings at Albuquerque and Santa Fe, New Mexico.
The transcripts of the hearings have been placed in the EPA Docket
supporting this final action (EDOCKET ID: OAR-2002-0005).
A. Proposed Changes to Sec. 194.6--Process for Adding Minor
Alternative Provisions
Section 194.6 establishes procedures applicable to substitution of
alternative provisions for any of the Compliance Criteria. Such
substitutions require a notice-and-comment rulemaking in accordance
with Sec. 194.6(a). In addition, Sec. 194.6 stipulates that EPA's
notice of proposed rulemaking (NPRM) addresses specific aspects of the
proposed substitution, includes a public comment period of at least 120
days, and public hearings in New Mexico.
Based on EPA's oversight experience at the WIPP and TRU waste
generator/storage sites, EPA proposed to revise Sec. 194.6 to add a
rulemaking process for substituting ``minor alternative provisions'' of
the Compliance Criteria. The proposed changes for Sec. 194.6 comport
fully with the radioactive waste disposal regulations at 40 CFR part
191 and would not substantively alter the scope of the TRU waste
disposal requirements. EPA also proposed to add to Sec. 194.2 the
definition of ``minor alternative provision'' to be a provision that
clarifies a regulatory provision without substantively altering the
existing regulatory requirement. Thus, revisions that do not alter the
intent or the approach to verifying compliance of an existing
regulatory requirement would be considered ``minor alternative
provisions.''
B. Proposed Changes to Sec. 194.8(b)--Waste Generator Site Inspection
and Approval Process
The information outlined in Sec. 194.8 describes the process by
which EPA inspects and approves waste characterization (WC) activities
at TRU waste sites. (For a detailed discussion, see 67 FR 51934-38.)
Previously, every time a TRU waste site sought approval of its WC
processes or TRU waste stream(s), EPA was required to conduct a site
inspection under the authority of Sec. 194.8. The Sec. 194.8 process
required EPA to issue a Federal Register notice announcing an
inspection, open a 30-day public comment period, and docket WC-related
material provided by the site for public review. The same process was
required to approve all subsequent expansions of the WC program to new
processes or waste streams at a site. Instead, we proposed that EPA
will conduct only a single baseline site inspection under Sec. 194.8
to determine whether a given site can adequately characterize TRU waste
and comply with the regulatory requirements imposed on the TRU waste
destined for the disposal at WIPP. Also, we proposed that all
additional inspections at an approved site would be conducted under
authority of Sec. 194.24(h) (not under Sec. 194.8) to approve changes
or expansions to the WC processes and waste streams approved during the
initial site approval referred to as the ``Baseline Compliance
Decision.'' (See discussion in IV.B below.) The second key change we
proposed was giving the opportunity for public comment on EPA's
proposed approval of the site's waste characterization program. The
proposed approval and accompanying inspection report would discuss
inspection results and the waste characterization program documentation
provided by the site. In addition, we proposed that the Agency would
issue a final approval decision only after consideration of the public
comments received in response to the proposed site approval.
EPA will issue a single Federal Register notice after each of the
initial baseline inspections. The public will be asked to comment on
the proposed approval and reporting requirements for each of the waste
generator sites. The results of all EPA site inspections (under Sec.
194.8 and Sec. 194.24) and other
[[Page 42573]]
relevant information/updates will be made available to the public in
EPA's dockets, WIPP Web site, and other means. We determined that the
revised process provides equivalent or improved oversight, more control
over schedule, better prioritization of technical issues and
distinctions, and flexibility to address relative levels of experience
or expertise at various DOE sites.
C. Proposed Changes to Sec. Sec. 194.12 and 194.13--Number and Form of
DOE Compliance Applications and Reference Materials
Section 194.12 of the Compliance Criteria requires DOE to submit 30
copies of the compliance applications and any accompanying materials to
the Administrator in printed form. This provision also applies to the
compliance applications periodically submitted by DOE for re-
certification of compliance. Section 194.13 requires that 10 printed
copies of referenced materials be submitted to the Administrator,
unless such materials are generally available.
We proposed to revise Sec. 194.12 to change the number of printed
copies of compliance applications and reference materials that DOE must
submit to EPA. We proposed to reduce the number of hard copies from 30
to 5 (one original and four printed copies). In addition, the proposed
revisions Sec. 194.12 required that DOE submit 10 complete compliance
applications by alternative means (e.g., compact disk) or other
approved format. Also, the Agency proposed to revise Sec. 194.13 by
changing the number of copies in printed form of the reference
materials from 10 to 5 and to require DOE to submit 10 copies of
reference materials by alternative means (e.g., compact disk) or other
approved format. We determined that the proposed revisions for
Sec. Sec. 194.12 and 194.13 would (a) improve the Agency's evaluation
process and reduce costs associated with the review of compliance
applications and reference materials; (b) enhance the public's access
to information via Internet ability to participate more actively in the
public comment process; and (c) reduce the number of copies in printed
form that must be submitted, thereby reducing paper usage.
D. Proposed Changes to Sec. Sec. 194.2 and 194.24(c)(3)--Terminology
Related to Waste Characterization
The Agency proposed to revise Sec. 194.24(c)(3) by replacing the
term ``process knowledge'' with the term ``acceptable knowledge.'' The
term ``acceptable knowledge'' has been used by EPA and DOE since the
Department submitted the Compliance Certification Application, during
both the certification rulemaking and subsequent site inspections. For
consistency, the Agency also proposed to add the definition of
``acceptable knowledge'' to Sec. 194.2.
III. What Is EPA's Final Action in Consideration of Public Comments?
Over the 120-day comment period for the proposed rule, EPA received
17 sets of comments (7 from the public hearings, 4 from EDOCKET, and 6
through e-mail/regular mail). During the two public hearings held in
Albuquerque and Santa Fe, New Mexico, 7 individuals presented their
views related to the proposal. This preamble responds to all major
comments.
The Response to Comments Document placed in the docket (EDOCKET
ID: OAR-2002-0005 discusses individual comments that EPA
received and EPA's responses to those comments. Below we discuss
changes that we made in response to the public comment and the
rationale for today's final action.
A. Summary of Comments and Final Changes to Sec. 194.6--Process for
Adding Minor Alternative Provisions
In the proposed rule, we discussed why EPA considers that the
existing provisions specific to minor revisions are unnecessarily
stringent and why the change is necessary (67 FR 51933-34). EPA's
oversight experience indicates that minor revisions to the Compliance
Criteria requirements may improve implementation and consistency in
regulatory compliance. Also, we acknowledged that for all alternative
provisions that do not meet the proposed definition of ``minor
alternative provisions,'' the Agency will continue to comply with the
current requirements of Sec. 194.6.
EPA proposed ``minor alternative provision'' as an alternative
provision that ``clarifies a regulatory provision, or does not
substantively alter the existing regulatory requirement.'' Thus,
revisions that do not alter the intent or the approach to verifying
compliance of an existing regulatory requirement are considered to
constitute minor alternative provisions. As examples, we cited the
proposed revisions to Sec. Sec. 194.2, 194.12, 194.13, and
194.24(c)(3) as minor revisions which the commenters supported (see
Response to Comments Document, EDOCKET ID: OAR-2002-0005).
Some commenters suggested an alternate definition to better clarify the
intent. In today's action, we have added additional language to the
definition to emphasize that a ``minor alternative provision'' would
only clarify an existing regulatory provision and not substantially
alter the regulatory requirements. The EPA is finalizing this
definition for ``minor alternative provision'' which comports fully
with the radioactive waste disposal regulations at 40 CFR part 191. In
addition, this definition does not substantively alter the scope of the
Compliance Criteria. More substantial revisions to 40 CFR part 194
would continue to follow the process laid out originally in Sec. 194.6
and now contained at Sec. 194.6(a). We believe this change will make
EPA's regulatory activities more efficient and improve the
implementation of minor revisions to the Compliance Criteria.
We proposed that a 30-day comment period is sufficient for the
public to provide the Agency with relevant input on such minor
revisions to the Compliance Criteria. In addition to the publication of
a proposed rule in the Federal Register for minor provisions, EPA
committed to announce the proposal on the Agency's Web site and place
all relevant supporting materials in the Agency's public docket. Public
comments expressed concern that a 30-day comment period is too short a
time to comment on EPA's proposals concerning minor revisions to the
Compliance Criteria. The streamlined process for minor provisions is
intended to apply to changes that provide clarification and are
uncontroversial or purely administrative--not highly technical or
complex actions. Therefore, the Agency believes that in most cases a
30-day comment period will be sufficient and has retained this minimum
requirement in the final rule. The Agency retains discretion to extend
the comment period when deemed necessary.
B. Summary of Comments and Final Changes to Sec. 194.8(b)--Waste
Generator Site Inspection and Approval Process
1. Background
As discussed in the proposed rule, the purpose of EPA inspections
at DOE sites is to verify that TRU waste sites are characterizing and
tracking waste to ensure the volume and characteristics of the wastes
conform with the requirements of the WIPP LWA and the specific
conditions of the Certification Decision. The requirements at Sec.
194.8(b) establish a process by which EPA determines whether DOE
complies with Condition 3 of the Certification Decision. This requires
that the Agency approve the programs for characterizing TRU waste
streams using the process set
[[Page 42574]]
forth in Sec. 194.8. (See 40 CFR part 194, appendix A.) Section 194.8
requires that, prior to sending waste from a generator site for
disposal at WIPP, DOE must implement and obtain EPA approval of the
``system of controls'' (that is, personnel, equipment, and procedures)
used at the site to characterize the waste and measure the waste
contents determined to be significant (i.e., ten significant
radionuclides, ferrous and non-ferrous metals, cellulosics, plastics
and paper) (63 FR 27392, May 18, 1998). Before approving DOE sites'
waste characterization activities, EPA must inspect individual sites to
verify that the sites have adequately implemented the proposed
characterization programs.
2. Baseline Inspection Process
Under the revised inspection and approval process, EPA proposed the
following changes (67 FR 51934-41; August 9, 2002):
Conduct a baseline inspection at all TRU waste generator/
storage sites once in accordance with the Sec. 194.8 requirements and
approve different WC program components based on the site's
demonstration of its capabilities;
Issue a Federal Register notice discussing Sec. 194.8
inspection results and EPA's proposed ``Baseline Compliance Decision.''
The notice will specify what subsequent WC program changes or expansion
must undergo further EPA inspection or approval under Sec. 194.24 by
assigning ``tiering'' designations to these activities. The notice will
provide in detail the reasons for supporting the approval of individual
WC program components, tier assignments and accompanying reporting
requirements, and any limitations.
Seek public comment on the proposed Baseline Compliance
Decision (i.e., comment on which activities should be assigned to each
tier) and place the supporting documents in the public docket as
described in Sec. 194.67; and
Evaluate and approve, if necessary, changes to the
approved WC program activities at all sites. Inspections necessary for
evaluation and/or approval of the changes will be conducted under
authority of Sec. 194.24(h), not under Sec. 194.8. (No change in the
continued compliance inspections at sites approved per the Baseline
Compliance Decision.)
Today, we are finalizing the above aspects of our proposed inspection
and approval process. We believe that these changes will not in any way
compromise EPA's ability to oversee TRU waste sites' compliance with
Sec. 194.24 requirements. Also, these changes will clearly delineate
the reasons for and the timing of the approval of different WC program
component changes and the waste streams that must be approved by EPA.
These changes will give TRU waste sites flexibility to seek limited or
broader approval during the initial inspection by demonstrating that
their WC programs can appropriately characterize a limited number or
wide spectrum of TRU wastes. EPA, under its continued compliance
authority, will verify that all sites characterize TRU wastes using
only the EPA-approved WC programs.
We believe these changes will not lessen, but rather strengthen our
ability to oversee DOE's TRU waste characterization activities and
monitor sites' compliance with Condition 3 of the WIPP Certification
Decision. The new process will not alter our authority or a site's
ability to limit or expand the scope of WC program components. Rather,
it will enable us to determine independently whether a subsequent
inspection is necessary, when it should occur or whether a decision to
allow a site to implement a change without EPA's approval is
appropriate.
Many commenters were very concerned that the revised approval
scheme would reduce the frequency of EPA inspections or even that once
approved, sites might be able to operate WC programs indefinitely with
little or no EPA oversight. They also expressed concern that the
proposed tiering process allows undue discretion by DOE in determining
what WC program changes at generator sites are significant. The
comments indicate that EPA did not make sufficiently clear the nature
and purpose of the proposed changes to the inspections process. In
response, we find that it is necessary to further clarify and elaborate
on the revised approval process and its implementation.
EPA does not believe that the proposed changes would reduce either
the number of inspections nor the level of oversight and enforcement at
DOE sites. The changes will modify the EPA inspection and approval
procedures, but will not necessarily affect the frequency or number of
times a site will be inspected. Under 40 CFR part 194, EPA may inspect
DOE TRU sites' waste characterization activities using the inspection
authority under Sec. 194.8 and Sec. 194.24. The new process provides
that the individual waste generator sites will need only one Sec.
194.8 approval from EPA to conduct WC activities. However, this single
Sec. 194.8 approval will specify any limitations on the approval that
will necessitate additional inspections by EPA. Any such additional
inspections will be conducted under authority of Sec. 194.24(h), not
under Sec. 194.8. Limitations on the initial Sec. 194.8 approval may
relate to waste streams, waste categories, processes, or other factors
deemed important by EPA and will specify what WC program expansions or
changes must undergo further EPA inspection or approval under Sec.
194.24. Furthermore, EPA's proposed Baseline Compliance Decision,
including any proposed limitations, will be subject to public comment.
The Agency does not agree that it is necessary to require a re-
evaluation of EPA's site-specific Baseline Compliance Decisions at a
set interval. As discussed in the preamble to the proposed rule and
reiterated above, EPA will conduct additional site inspections under
Sec. 194.24 to verify continued compliance with the baseline approval
in accordance with the tiering designations or as otherwise deemed
necessary. Since 1998, EPA has inspected WC programs at TRU waste sites
under Sec. 194.24 on an approximately annual basis. We are likely to
maintain at least the same frequency for future continued compliance
inspections under Sec. 194.24 and may inspect more frequently as
certain activities warrant. A reduced frequency of inspections might
also be warranted if, for example, a site has no characterization
activity over a period of time. The final rule offers flexibility in
scheduling inspections as necessary while not diminishing in any way
the effectiveness of our inspections program.
Generally, the Agency has conducted continuing compliance
inspections to coincide with DOE's annual recertification audits. In
its comments, DOE has requested that EPA continue to conduct the
baseline inspections at the approved sites when DOE performs these
audits. However, since the site inspections EPA would conduct to derive
the Baseline Compliance Decision would be more detailed than DOE's
annual recertification audits, these inspections will be scheduled by
EPA and may or may not coincide with the DOE's recertification audits.
Because EPA expects to continue to inspect sites regularly, we do
not believe it is necessary to specify an expiration date for the
baseline compliance approval. Through ongoing compliance inspections
(prompted by tiered activities/changes at the site or at EPA's own
discretion under Sec. 194.24), EPA will validate that approved
processes and equipment continue to be adequately implemented. The
baseline approval will remain valid so long as
[[Page 42575]]
the site continues to demonstrate appropriate use of approved
processes.
Table 1 provides a comparison of the previous site inspection/
approval process and the new Baseline Compliance Decision process. By
adopting the WC program approval process we are finalizing today, EPA
will achieve the following goals:
1. Maintain or improve oversight;
2. Improve public involvement and allow direct input in approval
decisions;
3. Allow greater discretion in establishing technical priorities
and accommodating varying degrees of WC experience at generator sites;
and
4. Reduce regulatory burden by limiting Federal Register
announcements under Sec. 194.8 that the Agency must issue, and allow
greater flexibility in scheduling inspections.
Table 1.--Current Approval and Baseline Compliance Decision Processes
----------------------------------------------------------------------------------------------------------------
Current inspection/ Baseline compliance
Activity approval process decision process Comment
----------------------------------------------------------------------------------------------------------------
Regulatory driver for waste Sec. 194.8........... Sec. 194.8........... Meet Condition 3 of the
characterization inspection. WIPP Certification
Decision.
Notifying EPA of its readiness....... Yes.................... Only new sites seeking EPA will inform each
initial approval. site with an approved
WC program the timing
for the inspection.
Announce inspection in Federal Every time a site seeks --Only for Baseline
Register notice. EPA approval to use a inspection to approve
new or modified WC site-specific WC
process or to ship any program.
new TRU waste stream --No FR announcements
or a group of waste for all followup tier-
streams for disposal. designated approvals.
Report information specific to WC DOE must provide waste --For the Baseline
processes. characterization plan inspection EPA will
and quality assurance tell sites the type of
program plan for each information needed.
initial approval. --For followup
inspections sites will
provide information
specified under each
of the WC process
tiers.
Assign tiers based on adequacies and No..................... Yes.................... Will require a
limitations of WC processes thorough, detailed
demonstrated. review to identify
situations that would
require EPA approval.
Require followup/additional Rarely................. Possible............... If the potential
inspections before approval. application of
different WC
components covers a
wide spectrum of TRU
waste streams.
Seeking public comment on the No..................... Yes....................
inspection results and pending
approval.
Issuing a site approval decision..... 30 days after the After the end of public Increased public
announcement of the comment period allowed involvement;
inspection in the to respond to the transparent decision
Federal Register. pending site approval process.
decision announced in
the Federal Register.
Require additional Sec. 194.8 For any new WC No..................... The need for additional
inspections. equipment/process or a Sec. 194.8
waste stream approval. inspections negated by
tiering signifying the
need for approval
under Sec. 194.24.
Inspect sites for continued Yes.................... Yes.................... To ensure that site is
compliance under Sec. 194.24 and using previously
issuing a letter and an inspection approved WC program
report. components to
characterize and
quantify TRU waste
contents.
Inspect sites to evaluate changes to When the site informs Identified by EPA as Eliminates
the approved WC processes. EPA of the need. part of the tiering interpretation and/or
assignments. guess work by site for
the need for EPA
approval.
----------------------------------------------------------------------------------------------------------------
When inspecting a waste generator site to render a Baseline
Compliance Decision, EPA inspectors will evaluate each WC program
component (equipment, procedure, and personnel training/experience) for
its adequacy and appropriateness in characterizing TRU waste destined
for WIPP disposal. The elements of this inspection will be the same as
those followed in the current site inspection process discussed in the
proposal (67 FR 51935-36). Depending on the site's demonstration of WC
capabilities, the baseline inspection could cover a broad spectrum of
WC processes and waste streams or could be limited to specific
equipment or one waste stream. During the inspection a site must
demonstrate its capabilities to characterize TRU waste(s) using
appropriate equipment, procedures, and personnel and comply with the
regulatory limits under Sec. 194.24. The site also must demonstrate
how the WC information is compiled and tracked using the EPA-approved
WIPP Waste Information System (WWIS).
Under today's rule, EPA's baseline approval will specify any
limitations on the approval. It will also specify what subsequent WC
program changes or expansion must undergo further EPA inspection or
approval under Sec. 194.24 by assigning ``tiers'' to each of these
activities. The tiering will be based on the following: Which WC
processes the site has demonstrated to be suitable to and capable of
characterizing a given
[[Page 42576]]
TRU waste type and the historical knowledge about the physical and
radiological waste characteristics. EPA will assign the tiering
designations. This eliminates the possibility of misinterpretation on
DOE's part and the possibility of EPA not agreeing with DOE's selection
of a tier. In addition, the public will have the opportunity to comment
on which activities should be assigned to each tier.
EPA would like to further clarify the details of the tiers. Tier 1
waste characterization activities at a site will have more stringent
reporting requirements. These activities will require notification by
DOE and approval by EPA prior to shipment of waste to the WIPP. We
expect to conduct site inspections as part of our decision-making
process for many Tier 1 activities. Tier 2 activities will have more
moderate reporting requirements and EPA may approve changes to certain
activities without a follow-up inspection (i.e., desktop review and
approval of certain technical documents). These activities will require
a notification by DOE to EPA on the specific changes; however, waste
can be shipped to the WIPP without prior Agency approval. For Tier 2
notifications, EPA will review the documentation provided by DOE and
reply only if additional information or analysis is needed. Other
changes (i.e., if no tier is specified) will be captured in DOE's
annual change reports or continuing compliance inspections under Sec.
194.24.
DOE will report any changes in equipment, processes, or personnel,
based on their tier level, and certain changes must be reported to EPA
before the sites are allowed to ship waste using the waste
characterization activities in question. EPA will then decide whether
or not a follow-up inspection is necessary to confirm and verify the
adequacy of any changes to the site's waste characterization program.
EPA may also conduct unannounced site inspections of a tiered activity
if EPA determines a need based on the available information. Below are
examples of how the tiers may be assigned:
In its baseline inspection by EPA, a site (``Site 1'' in
this example) demonstrates that it can quantify 10 WIPP-tracked
radionuclides only in homogeneous organic solids using a particular
piece of radioassay equipment (``Equipment A'' in this example). The
baseline approval for Site 1 is issued and the non-destructive assay
(NDA) equipment is approved with the limitation that it may be used to
characterize only homogeneous solids. As part of the baseline approval,
the change to use Equipment A on a new waste stream is designated a
Tier 1 change. Therefore, if Site 1 would like to use Equipment A to
characterize inorganic sludge then an additional EPA approval will be
necessary.
Site 1 would now like to use a different piece of
equipment (``Equipment B'' in this example) to characterize the same
waste stream that they are already approved for (in this case,
homogeneous solids). Equipment B is nearly identical to Equipment A in
specifications and operating controls. As part of the baseline
approval, EPA specifies that using equivalent equipment to characterize
an approved waste stream is a Tier 2 change. Therefore, Site 1 notifies
EPA of its plans, provides documentation to EPA that Equipment A and B
are equivalent, and can install and operate the new equipment without
prior approval by the Agency.
For both Tier 1 and 2 changes, DOE must submit to EPA information
discussing the relevant program changes for our evaluation. Prior to
approval, Tier 1 changes may require an inspection to obtain objective
evidence demonstrating a site's WC program adequacy and WC data showing
compliance with the WIPP compliance criteria at 40 CFR 194. EPA will
docket and post information from these Sec. 194.24 inspections on the
WIPP Web site for public review. Generally, Tier 2 changes would not
require inspections, provided that EPA is satisfied with the
information submitted by DOE regarding the changes. EPA's approval
letter discussing Tier 1 or Tier 2 changes would explain how the
available information was sufficient to justify a decision, or what
additional information was collected during an inspection, if one was
conducted. Also, EPA will docket and post on the WIPP Web site the Tier
2 approval letter and DOE submission for public review.
Major sites with an approved waste characterization program
(Hanford, LANL, INEEL, RFETS, and SRS) and those requiring EPA approval
(such as Oak Ridge National Laboratory) will be subject to a mandatory
inspection to render the site-specific Baseline Compliance Decision and
accompanying tiers. A few commenters misconstrued that once the Agency
renders a Baseline Compliance Decision specific to the DOE's Central
Characterization Project (CCP), the CCP can apply the approved WC
activities at any TRU site. Commenters are incorrect with their
understanding of the limitations of EPA's CCP approval. Currently, EPA
inspects and approves the CCP program at each site and the approval is
site-specific whenever a site hires CCP to characterize their TRU
waste. EPA has followed this approach and has approved the CCP WC
activities at the SRS, ANL-E, and NTS. Once today's rule becomes
effective, EPA will inspect the above major sites with approved WC
programs, sites with the approved CCP WC activities, and the remaining
TRU waste generator/storage sites and render a Baseline Compliance
Decision specific to each individual site. Each TRU site with an
approved WC program may continue to dispose of their approved TRU waste
streams at the WIPP. All TRU waste sites remain subject to applicable
Federal and State regulations governing packaging, transportation, and
disposal regulations for TRU waste.
Once the Baseline Compliance Decision has been made and tiers have
been assigned at each site, the EPA may decide to revise the tiering
designations, based on a variety of factors. Some sites may have a
harder time converting to the more robust inspections regime, and
certain aspects of their WC program that were strong in the past may
need more intense scrutiny. Conversely, certain sites will undoubtedly
improve their overall performance as they become accustomed to the new
system, and certain aspects of their WC program will subsequently
require less attention.
The decision to revise tiers at a site will be made through
continued compliance inspections under the authority of Sec.
194.24(h), as previously discussed. The Agency will announce the
proposed tier changes and the reasoning behind them in the site's
inspection report, which will be posted on the WIPP Web site and
docketed in accordance with Sec. 194.67. If the tier change is an
elevation in stringency from Tier 2 to Tier 1 (i.e., additional DOE
reporting requirements for that particular waste characterization
component or activity), the change will be effective immediately and
the site will be expected to operate under the more stringent
requirements without delay. If, however, the change is a ``downgrade''
in stringency from Tier 1 to Tier 2, the inspection report will solicit
comments from the public, for a minimum of 30 days, to let them raise
any concerns they might have. The site will continue to operate under
the more stringent tier designation until public comment can be
considered.
The site inspections necessary to develop the Baseline Compliance
Decision have three components which we will include in our inspection
report: (a) Description of what we inspected and found to be
technically
[[Page 42577]]
adequate; (b) tiering of WC elements and the basis for the tiering
assignment; and (c) identification of site's subsequent reporting
requirements for the specific WC elements. Currently, EPA inspection
reports describe what we inspect, what we determine to be technically
adequate, what we identify as deficiencies and whether any corrective
action is required before EPA approval. Under the new process, we will
continue to complete a report containing these elements. In addition,
the inspection will allow us to determine WC component modifications
requiring EPA approval.
The results of all EPA site inspections (and their accompanying
inspection reports), under Sec. 194.8 and Sec. 194.24, will be made
available to the public in EPA's dockets, WIPP Web site, and other
means. If, at any time, we determine that the system of controls at a
site is not adequate to characterize certain waste streams, EPA retains
authority to direct that the site may not dispose of material from
those waste streams or processes at the WIPP until the Agency's
findings have been adequately resolved.
3. Opportunity for Public Comment & Length of Public Comment Periods
As previously discussed, the Agency aims to improve public
participation by providing an opportunity to comment on EPA inspection
reports and proposed approval decision in addition to DOE program
documents and other information. Thus, the public would be well
informed about the inspection that was performed, which decisions are
proposed and why, and can provide comments related to the approval and
tiering process.
After completing the baseline Sec. 194.8 inspections to determine
capabilities and adequacy of WC program at each TRU site, EPA will
prepare an inspection report discussing the inspection process and the
findings and/or concerns. The site-specific inspection report will
discuss various WC process-specific tiers and their basis. They will
also contain subsequent reporting requirements for the WC program
components. Using this information, we will issue the proposed Baseline
Compliance Decision in the Federal Register for public comment (see
discussion for the public comment period below). In addition, we will
make available in the EPA Docket our inspection report and the site-
specific waste characterization documents for public review. Most
commenters responding to this issue supported the proposal. One
commenter contended that this would result in unnecessary operational
delays and costs. As discussed in the Response to Comments Document
(See EDOCKET ID: OAR-2002-0005), EPA does not agree with the
reasoning as the approved TRU sites can continue to dispose of their
approved waste streams at the WIPP.
Today, we are finalizing a 45-day comment period when seeking
public comment related to EPA's site-specific Baseline Compliance
Decision and associated tier assignments. Several commenters stated
that a 30-day comment period is not adequate, especially considering
the amount and nature of the technical material kept in the docket and
commenters' other work priorities. As discussed in the Response to
Comments Document (EDOCKET ID: OAR-2002-0005), the public-
notice-and-approval process described in Sec. 194.8(b) has not yielded
the level of comment that we anticipated.
Over the past 4 years, EPA has made every effort to inform public
of EPA inspections when necessary by issuing a Federal Register notice
and posting updates on the EPA's WIPP Web site. DOE documents and other
material related to these inspections has also been docketed at each of
our docket locations. However, we recognize that the highly technical
nature of the documents available for comment may have discouraged
public participation. In recognition of this, the changes to the site
approval process include significant changes to the public comment
process. The changes allow for comment not only on DOE's technical
documents, but also on EPA's proposed decision on site approval. The
public will also be able to comment directly on the proposed tiering
designations (and associated level of EPA review and approval) for
subsequent changes or expansions of the WC program at a given site. A
minimum 45-day comment period will be opened for the proposed Baseline
Compliance Decisions at each site. As a general rule, EPA will allow 45
days for receiving public comment and may provide additional time on a
case-by-case basis when needed. Thus, the public will have an
opportunity to review and comment on EPA's proposed Baseline Compliance
Decisions and inspection reports prior to site approvals.
The Agency also acknowledges that the Federal Register is not the
only effective tool for providing information to the public. Under
these revisions, EPA will issue a Federal Register notice for the
initial Baseline Compliance Decision at each site. EPA also expects to
use e-mail, web updates, and other more user-friendly communication
tools to notify stakeholders of the occurrence and results of baseline
approvals and subsequent ongoing inspections.
As discussed previously (see Section III.B.2), if EPA deems that a
change in tiering designation (from Tier 1 to Tier 2) at a site is
warranted, the Agency will announce the proposed changes and the
reasoning behind them in the site's inspection report, which will be
posted on the WIPP Web site and placed in the dockets. EPA will also
open a minimum 30-day comment period on the proposed change. However,
where circumstances warrant, EPA will consider a longer comment period.
4. Time Frame and Effective Date
Although today's actions will be effective on October 14, 2004, EPA
expects that the baseline compliance inspections and approval process
will be more wide-ranging than the current inspection regime since it
will not be limited by waste stream designations and will explicitly
address future expansions of the characterization program. The first
approvals conducted under the new process are likely to be highly
detailed and very intensive, since EPA will need to work with DOE and
stakeholders to ensure that the full range of waste characterization
activities is identified and placed in appropriate reporting/approval
tiers. The final rule provides important flexibility to ensure that EPA
can effectively implement--and that the public can fully understand and
participate in--the new process. First, the final rule does not
establish a time period within which EPA must ``convert'' sites to the
new inspections and approval process. DOE sites with approved waste
characterization programs will be allowed to continue operations under
the existing inspection and approval process based on waste streams;
the waste stream system, while less flexible than the newly revised
process, remains rigorous and can continue to provide effective
oversight during the transition period. We expect to review approved
programs and issue new baseline approval decisions for those sites
within approximately two years. However, the Agency retains the
discretion to take longer (if warranted) by the complexity of technical
issues or the scope of more comprehensive inspections. Similarly, we
decline to limit the length of the comment period on proposed baseline
approval decisions. We believe that limiting the available comment
period would be counterproductive for both EPA and the public in
adjusting to the new process, and could constrain discussion if
unanticipated or especially complex issues arise.
[[Page 42578]]
5. Consideration of Resources
A few commenters endorsed the proposed changes to Sec. 194.8, but
did not necessarily agree with EPA's resource rationale. The Agency
believes that the proposed changes are fully justifiable on a technical
basis, as outlined above in Section III.B.2. While resource
consideration is a valid factor, the discussion of resources in the
preamble to the proposal may have been misleading in regard to its
relative importance. The revised process provides equivalent or
improved oversight, more control over schedule, better prioritization
of technical issues and distinctions, and flexibility to address
relative levels of experience or expertise at various DOE sites.
6. Compliance of Waste Generator Sites and the WIPP Facility
Some commenters expressed concern about the reference in the
proposed Sec. 194.8(b)(3)(i) to Sec. 194.48(b)(1) and (2). They
suggested that the provisions of Sec. 194.4 are specific to the WIPP
site itself and are not appropriate responses to noncompliance at a
waste generator site. The Agency disagrees with those statements.
Section 194.8(b)(4)(i) provides that EPA may suspend shipments of TRU
waste from an approved TRU waste site if EPA subsequently determines
that waste characterization programs or processes are not adequately
established or implemented. In addition, if necessary, EPA may take
action under Sec. 194.4(b)(1) or (2). Section 194.4(b)(1) provides
that EPA may suspend, modify, or revoke the certification of the WIPP.
Suspension may be at the discretion of EPA; modification or revocation
will be conducted by rule pursuant to 5 U.S.C. 553. Section
194.8(b)(3)(i) provides that EPA may request that DOE provide
information to enable EPA to determine whether suspension,
modification, or revocation of the certification is warranted. DOE's
inability to properly establish, maintain, or implement adequate waste
characterization activities at a waste generator site could lead to
circumstances that necessitate consideration of suspension,
modification, or revocation of the WIPP certification. Poorly and/or
inadequately characterized waste when emplaced in the repository could
be relevant to determining the long-term performance of the WIPP.
Therefore, EPA disagrees that the provisions of Sec. 194.4(b) are
specific only to the WIPP facility, and can never be relevant to
activities at a waste generator site.
C. Summary of Comments and Final Changes to Sec. Sec. 194.12 and
194.13--Number and Form of DOE Compliance Applications and Reference
Materials
EPA proposed to revise Sec. 194.12 by changing the number of
copies of compliance applications in printed form from 30 to 5 (one
original and four printed copies). In addition, the Agency proposed to
revise Sec. 194.12 by requiring that DOE submit 10 complete compliance
applications in alternative format (e.g., compact disk) or other
approved format. (For a detailed discussion, see 67 FR 51941-42.)
Also, the Agency proposed to revise Sec. 194.13 by changing the
number of copies in printed form of the reference materials from 10 to
5 and to require DOE to submit 10 copies of reference materials in
alternative format (e.g., compact disk) or other approved format.
Public comments were supportive of these proposed actions and
therefore, we are finalizing the proposed requirements under Sec.
194.12 and Sec. 194.13. Commenters requested clarification that EPA's
WIPP dockets would continue to be provided paper copies of application
materials for public review. In accordance with Sec. 194.67, the paper
copies of compliance applications and related materials will be placed
in the official docket in Washington, DC, and at the four informational
dockets in New Mexico.
D. Summary of Comments and Final Changes to Sec. Sec. 194.2 and
194.24(c)(3)--Terminology Related to Waste Characterization
Section 194.24, waste characterization, generally requires DOE to
identify, quantify, and track the chemical, physical, and radiological
components of the waste destined for disposal at WIPP that may
influence disposal system performance. Section 194.24(c)(3) requires
DOE to demonstrate that the use of process knowledge to quantify waste
components conforms with the quality assurance (QA) requirements
outlined in Sec. 194.22. To demonstrate compliance, DOE must have
information and documentation to substantiate that process knowledge
data acquired and used during waste characterization activities are in
compliance with the QA requirements.
The Agency proposed to revise Sec. 194.24(c)(3) by replacing the
term ``process knowledge'' with the term ``acceptable knowledge.'' The
term ``acceptable knowledge'' has been the term used by EPA and DOE
since DOE submitted the Compliance Certification Application, during
both the certification rulemaking and subsequent site inspections. Use
of the term ``acceptable knowledge'' in Sec. 194.24(c)(3) in lieu of
``process knowledge'' will not alter our technical approach to
verifying compliance during an inspection; rather, it will reflect our
actual practice more accurately. (For a detailed discussion, see 67 FR
51942-43.)
For consistency with the change being proposed today for Sec.
194.24(c)(3), the Agency also proposed to add the following definition
of ``acceptable knowledge'' to Sec. 194.2: ``Acceptable knowledge
means any information about the process used to generate waste,
material inputs to the process, and the time period during which the
waste was generated, as well as data resulting from the analysis of
waste conducted prior to or separate from the waste certification
process authorized by EPA's Certification Decision, to show compliance
with Condition 3 of the certification decision (40 CFR part 194,
appendix A).''
Both of these changes as proposed were supported by commenters and
therefore, we are finalizing the definition of ``acceptable knowledge''
in Sec. Sec. 194.2 and 24(c)(3).
IV. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, (58 FR 51735; October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines ``significant regulatory action'' as
one that is likely to result in a rule that may: (1) Have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. It has been determined
that this rule is not a ``significant regulatory action'' under the
terms of Executive Order 12866 and is therefore not subject to OMB
review.
[[Page 42579]]
B. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective 90 days from publication in the
Federal Register.
C. Regulatory Flexibility Act
Today's final rule is not subject to the RFA, which generally
requires an agency to prepare a regulatory flexibility analysis for any
rule that will have a significant economic impact on a substantial
number of small entities. The RFA applies only to rules subject to
notice-and-comment rulemaking requirements under the Administrative
Procedure Act (APA) or any other statute. This rule is not subject to
notice and comment requirements under the APA or any other statute.
This rule pertains to agency management or personnel, which the APA
expressly exempts from notice-and-comment rulemaking requirements. 5
U.S.C. 533(a)(2).
Although this final rule is not subject to the RFA, EPA nonetheless
has assessed the potential of this rule to adversely impact small
entities subject to the rule. Small entities include small businesses,
small not-for-profit enterprises, and small governmental jurisdictions.
This final rule will not have a significant economic impact on a
substantial number of small entities because it sets forth requirements
which apply only to Federal agencies.
D. Paperwork Reduction Act
This final action does not impose an information collection burden
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq. The Compliance Criteria (in 40 CFR part 194) requirements are
applicable only to DOE and EPA and do not establish any form of
collection of information from the public. Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information.
An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
E. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
Today's final rule contains no Federal mandates (under the
regulatory provisions of Title II of the UMRA) for State, local, or
tribal governments or the private sector. This rule applies only to
Federal agencies. Thus, today's rule is not subject to the requirements
of sections 202 and 205 of the UMRA.
F. Executive Order 12898: Environmental Justice Strategy
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations,'' the Agency has considered
environmental justice related issues with regard to the potential
impacts of this action on the environmental and health conditions in
low-income, minority, and native American communities. We have complied
with this mandate. However, the requirements specifically set forth by
the Congress in the Waste Isolation Pilot Plant Land Withdrawal Act
(Pub. L. 102-579), which prescribes EPA's role at the WIPP, did not
provide authority for EPA to examine impacts in the communities in
which wastes are produced, stored, and transported, and Congress did
not delegate to EPA the authority to consider the issue of alternative
locations for the WIPP.
During the development of the existing provisions in 40 CFR part
194, the EPA involved minority and low-income populations early in the
rulemaking process. In 1993, EPA representatives met with New Mexico
residents and government officials to identify the key issues that
concern them, the types of information they wanted from EPA, and the
best ways to communicate with different sectors of the New Mexico
public. The feedback provided by this group of citizens formed the
basis for EPA's WIPP communications and consultation plan. To help
citizens (including a significant Hispanic population in Carlsbad and
the nearby Mescalero Indian Reservation) stay abreast of EPA's WIPP-
related activities, the Agency developed many informational products
and services. The EPA translated into Spanish several documents
regarding WIPP, including educational materials and fact sheets
describing EPA's WIPP oversight role and the radioactive waste disposal
standards. The EPA also established a toll-free WIPP Information Line,
recorded in both English and Spanish,
[[Page 42580]]
providing the latest information on upcoming public meetings,
publications, and other WIPP-related activities. The EPA also developed
a mailing list, which includes many low-income, minority, and native
American groups, to systematically provide interested parties with
copies of EPA's public information documents and other materials. Even
after the final rule, in 1998, EPA has continued to implement outreach
services to all WIPP communities based on the needs determined during
the certification.
This final action does not add or delete any certification
criteria. The rule will revise the public notice process for the
approval of waste characterization activities at DOE waste generator
sites, which produce and store wastes destined for disposal at WIPP.
Affected communities and the public in general would have the
opportunity to comment on EPA's proposed waste generator site approval
decision. The existing provision does not offer such opportunity. The
proposed revision makes the public comment period more meaningful to
all communities. The Agency also intends to continue its outreach
activities to make information on waste characterization activities
more accessible by using the Internet, EPA information line, and fact
sheets.
G. National Technology Transfer & Advancement Act of 1995
Section 12 of the National Technology Transfer & Advancement Act of
1995 is intended to avoid ``re-inventing the wheel.'' It aims to reduce
costs to the private and public sectors by requiring federal agencies
to draw upon any existing, suitable technical standards used in
commerce or industry. To comply with the Act, EPA must consider and use
``voluntary consensus standards,'' if available and applicable, when
implementing policies and programs, unless doing so would be
``inconsistent with applicable law or otherwise impractical.'' We have
determined that this regulatory action is not subject to the
requirements of National Technology Transfer & Advancement Act of 1995
as this rulemaking is not setting any technical standards.
H. Executive Order 13045: Children's Health Protection
Executive Order 13045: ``Protection of Children from Environmental
health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Order has the
potential to influence the regulation. This rule is not subject to
Executive Order 13045 because it does not establish an environmental
standard intended to mitigate health or safety risks.
I. Executive Order 13132: Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This final action revises
specific portions of the Compliance Criteria in 40 CFR part 194. These
criteria are applicable only to DOE (operator) and EPA (regulator) of
the WIPP disposal facility. Thus, Executive Order 13132 does not apply
to this rule.
J. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This final rule does not have
tribal implications, as specified in Executive Order 13175. This
proposed action revises specific portions of the Compliance Criteria in
40 CFR part 194. The Compliance Criteria are applicable only to Federal
agencies. Thus, Executive Order 13175 does not apply to this rule.
K. Executive Order 13211: Energy Effects
This final rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355; May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.
List of Subjects in 40 CFR Part 194
Environmental protection, Administrative practice and procedure,
Nuclear materials, Radionuclides, Plutonium, Radiation Protection,
Uranium, Transuranics, Waste Treatment and Disposal.
Dated: July 8, 2004.
Michael O. Leavitt,
Administrator.
0
For the reasons set out in the preamble, 40 CFR part 194 is amended as
follows.
PART 194--CRITERIA FOR THE CERTIFICATION AND RE-CERTIFICATION OF
THE WASTE ISOLATION PILOT PLANT'S COMPLIANCE WITH THE 40 CFR PART
191 DISPOSAL REGULATIONS
0
1. The authority citation for part 194 continues to read as follows:
Authority: Pub. L. 102-579, 106 Stat. 4777, as amended by Pub.
L. 104-201, 110 Stat. 2422; Reorganization Plan No. 3 of 1970, 35 FR
15623, Oct. 6, 1970, 5 U.S.C. app. 1; Atomic Energy Act of 1954, as
amended, 42 U.S.C. 2011-2296 and 10101-10270.
0
2. Section 194.2, is amended by adding definitions in alphabetical
order for ``Acceptable knowledge'' and ``Minor alternative provision''
to read as follows:
Sec. 194.2 Definitions.
* * * * *
Acceptable knowledge means any information about the process used
to generate waste, material inputs to the process, and the time period
during which the waste was generated, as well as data resulting from
the analysis of waste, conducted prior to or separate from the waste
certification process authorized by EPA's Certification Decision, to
show compliance with Condition 3 of the certification decision (
appendix A of this part).
* * * * *
Minor alternative provision means an alternative provision to the
Compliance
[[Page 42581]]
Criteria that only clarifies an existing regulatory provision, or does
not substantively alter the existing regulatory requirements.
* * * * *
0
3. Section 194.6 is revised to read as follows:
Sec. 194.6 Alternative provisions.
The Administrator may, by rule pursuant to 5 U.S.C. 553, substitute
for any of the provisions of this part alternative provisions, or minor
alternative provisions, in accordance with the following procedures:
(a) Alternative provisions may be substituted after:
(1) Alternative provisions have been proposed for public comment in
the Federal Register together with information describing how the
alternative provisions comport with the disposal regulations, the
reasons why the existing provisions of this part appear inappropriate,
and the costs, risks and benefits of compliance in accordance with the
alternative provisions;
(2) A public comment period of at least 120 days has been completed
and public hearings have been held in New Mexico;
(3) The public comments received have been fully considered; and
(4) A notice of final rulemaking is published in the Federal
Register.
(b) Minor alternative provisions may be substituted after:
(1) The minor alternative provisions have been proposed for public
comment in the Federal Register together with information describing
how they comport with the disposal regulations, the reasons why the
existing provisions of this part appear inappropriate, and the benefit
of compliance in accordance with the minor alternative provision;
(2) A public comment period of at least 30 days has been completed
for the minor alternative provisions and the public comments received
have been fully considered;
(3) A notice of final rulemaking is published in the Federal
Register for the minor alternative provisions.
0
4. Section 194.8 is amended:
0
a. By redesignating paragraph (b) as paragraph (c);
0
b. By adding a new paragraph (b) and revising newly designated
paragraph (c) to read as follows:
Sec. 194.8 Approval process for waste shipment from waste generator
sites for disposal at the WIPP.
* * * * *
(b) Waste characterization programs at transuranic waste sites. The
Agency will establish compliance with Condition 3 of the certification
using the following process:
(1) DOE will implement waste characterization programs and
processes in accordance with Sec. 194.24(c)(4) to confirm that the
total amount of each waste component that will be emplaced in the
disposal system will not exceed the upper limiting value or fall below
the lower limiting value described in the introductory text of Sec.
194.24(c). Waste characterization processes will include the collection
and use of acceptable knowledge; destructive and/or nondestructive
techniques for identifying and measuring waste components; and the
validation, control, and transmittal to the WIPP Waste Information
System database of waste characterization data, in accordance with
Sec. 194.24(c)(4).
(2) The Agency will verify the compliance of waste characterization
programs and processes identified in paragraph (b)(1) of this section
at sites without EPA approval prior to October 14, 2004, using the
following process:
(i) DOE will notify EPA by letter that a transuranic waste site is
prepared to ship waste to the WIPP and has established adequate waste
characterization processes and programs. DOE also will provide the
relevant waste characterization program plans and documentation. EPA
may request additional information from DOE.
(ii) EPA will conduct a baseline compliance inspection at the site
to verify that adequate waste characterization program plans and
technical procedures have been established, and that those plans and
procedures are effectively implemented. The inspection will include a
demonstration or test by the site of the waste characterization
processes identified in paragraph (b)(1) of this section. If an
inspection does not lead to approval, we will send an inspection report
to DOE identifying deficiencies and place the report in the public
docket described in Sec. 194.67. More than one inspection may be
necessary to resolve compliance issues.
(iii) The Agency will announce in the Federal Register a proposed
Baseline Compliance Decision to accept the site's compliance with Sec.
194.24(c)(4). We will place the inspection report(s) and any supporting
documentation in the public docket described in Sec. 194.67. The site
inspection report supporting the proposal will describe any limitations
on approved waste streams or waste characterization processes. It will
also identify (through tier designations in accordance with paragraph
(b)(4) of this section) what changes to the approved waste
characterization processes must be reported to and approved by EPA
before they can be implemented. In the notice, we will solicit public
comment (for a minimum of 45 days) on the proposed Baseline Compliance
Decision, including any limitations and the tier designations for
future changes or expansions to the site's waste characterization
program.
(iv) Our written decision regarding compliance with the
requirements for waste characterization programs and processes
described in paragraph (b)(1) of this section will be conveyed in a
letter from the Administrator's authorized representative to DOE. EPA
will not issue a compliance decision until after the end of the public
comment period described in paragraph (b)(2)(iii) of this section.
EPA's compliance decision will respond to significant and timely-
received comments. A copy of our compliance decision will be placed in
the public docket described in Sec. 194.67. DOE will comply with any
requirements identified in the compliance decision and the accompanying
inspection report.
(3) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iv) of this section, the Agency intends
to conduct inspections, in accordance with Sec. 194.24(h), to confirm
the continued compliance of approved waste characterization programs
and processes at transuranic waste sites. EPA will make the results of
these inspections available to the public in the dockets described in
Sec. 194.67.
(4) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iv) of this section, the Department must
report changes or expansions to the approved waste characterization
program at a site in accordance with the tier designations established
in the Baseline Compliance Decision.
(i) For changes or expansions to the waste characterization program
designated as ``Tier 1,'' the Department shall provide written
notification to the Agency. The Department shall not ship for disposal
at WIPP any waste that has been characterized using the new or revised
processes, equipment, or waste streams until EPA has provided written
approval of such new or revised systems.
(ii) For changes or expansions to the waste characterization
program designated as ``Tier 2,'' the Department shall provide written
notification to the Agency. Waste characterized using the new or
revised processes, equipment, or
[[Page 42582]]
waste streams may be disposed at WIPP without written EPA approval.
(iii) EPA may conduct inspections in accordance with Sec.
194.24(h) to evaluate the implementation of Tier 1 and Tier 2 changes
or expansions to the waste characterization program at a site.
(iv) Waste characterization program changes or expansions that are
not identified as either ``Tier 1'' or ``Tier 2'' will not require
written notification by the Department to the Agency before
implementation or before shipping waste for disposal at WIPP.
(5) Subsequent to any positive determination of compliance as
described in paragraph (b)(2)(iii) of this section, EPA may revise the
tier designations for approving changes or expansions to the waste
characterization program at a site using the following process:
(i) The Agency shall announce the proposed tier changes in a letter
to the Department. The letter will describe the Agency's reasons for
the proposed change in tier designation(s). The letter and any
supporting inspection report(s) or other documentation will be placed
in the dockets described in Sec. 194.67.
(ii) If the revised designation entails more stringent notification
and approval requirements (e.g., from Tier 2 to Tier 1, or from
undesignated to Tier 2), the change shall become effective immediately
and the site shall operate under the more stringent requirements
without delay.
(iii) If the revised designated entails less stringent notification
and approval requirements, (e.g., from Tier 1 to Tier 2, or from Tier 2
to undesignated), EPA will solicit comments from the public for a
minimum of 30 days. The site will continue to operate under the more
stringent approval requirements until the public comment period is
closed and EPA notifies DOE in writing of the Agency's final decision.
(6) A waste generator site that EPA approved for characterizing and
disposing transuranic waste at the WIPP under this section prior to
October 14, 2004, may continue characterizing and disposing such waste
at the WIPP under paragraph (c) of this section until EPA has conducted
a baseline compliance inspection and provided a Baseline Compliance
Decision under paragraph (b)(2) of this section.
(i) Until EPA provides a Baseline Compliance Decision for such a
site, EPA may approve additional transuranic waste streams for disposal
at WIPP under the provisions of paragraph (c) of this section. Prior to
the effective date of EPA's Baseline Compliance Decision for such a
site, EPA will continue to conduct inspections of the site in
accordance with Sec. 194.24(c).
(ii) EPA shall conduct a baseline compliance inspection and issue a
Baseline Compliance Decision for such previously approved sites in
accordance with the provisions of paragraph (b) of this section, except
that the site shall not be required to provide written notification of
readiness as described in paragraph (b)(2)(i) of this section.
(c) Waste characterization programs at waste generator sites with
prior approval. For a waste generator site that EPA approved for
characterizing and disposing transuranic waste at the WIPP under this
section prior to October 14, 2004, the Agency will determine compliance
with the requirements for use of process knowledge and a system of
controls at waste generator sites as set in this paragraph (c).
Approvals for a site to characterize and dispose of transuranic waste
at WIPP will proceed according to this section only until EPA has
conducted a baseline compliance inspection and provided a Baseline
Compliance Decision for a site under paragraph (b)(2) of this section.
(1) For each waste stream or group of waste streams at a site, the
Department must:
(i) Provide information on how process knowledge will be used for
waste characterization of the waste stream(s) proposed for disposal at
the WIPP; and
(ii) Implement a system of controls at the site, in accordance with
Sec. 194.24(c)(4), to confirm that the total amount of each waste
component that will be emplaced in the disposal system will not exceed
the upper limiting value or fall below the lower limiting value
described in the introductory text of Sec. 194.24(c). The
implementation of such a system of controls shall include a
demonstration that the site has procedures in place for adding data to
the WIPP Waste Information System (``WWIS''), and that such information
can be transmitted from that site to the WWIS database; and a
demonstration that measurement techniques and control methods can be
implemented in accordance with Sec. 194.24(c)(4) for the waste
stream(s) proposed for disposal at the WIPP.
(2) The Agency will conduct an audit or an inspection of a
Department audit for the purpose of evaluating the use of process
knowledge and the implementation of a system of controls for each waste
stream or group of waste streams at a waste generator site. The Agency
will announce a scheduled inspection or audit by the Agency with a
notice in the Federal Register. In that or another notice, the Agency
will also solicit public comment on the relevant waste characterization
program plans and Department documentation, which will be placed in the
dockets described in Sec. 194.67. A public comment period of at least
30 days will be allowed.
(3) The Agency's written decision regarding compliance with the
requirements for waste characterization programs described in paragraph
(b)(1) of this section for one or more waste streams from a waste
generator site will be conveyed in a letter from the Administrator's
authorized representative to the Department. No such compliance
determination shall be granted until after the end of the public
comment period described in paragraph (b)(2) of this section. A copy of
the Agency's compliance determination letter will be placed in the
public dockets in accordance with Sec. 194.67. The results of any
inspections or audits conducted by the Agency to evaluate the plans
described in paragraph (b)(1) of this section will also be placed in
the dockets described in Sec. 194.67.
(4) Subsequent to any positive determination of compliance as
described in paragraph (b)(3) of this section, the Agency intends to
conduct inspections, in accordance with Sec. Sec. 194.21 and
194.24(h), to confirm the continued compliance of the programs approved
under paragraphs (b)(2) and (b)(3) of this section. The results of such
inspections will be made available to the public through the Agency's
public dockets, as described in Sec. 194.67.
0
5. Section 194.12 is revised to read as follows:
Sec. 194.12 Submission of compliance applications.
Unless otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of any compliance
application(s), any accompanying materials, and any amendments thereto
shall be submitted in a printed form to the Administrator's authorized
representative. These paper copies are intended for the official docket
in Washington, DC, as well as the four informational dockets in
Albuquerque and Santa Fe, New Mexico. In addition, DOE shall submit 10
copies of the complete application in alternative format (e.g., compact
disk) or other approved format, as specified by the Administrator's
authorized representative.
0
6. Section 194.13 is revised to read as follows:
Sec. 194.13 Submission of reference materials.
Information may be included by reference into compliance
[[Page 42583]]
applications(s), provided that the references are clear specific and
that unless, otherwise specified by the Administrator or the
Administrator's authorized representative, 5 copies of reference
information are submitted to the Administrator's authorized
representative. These paper copies are intended for the official docket
in Washington, DC, as well as the four informational dockets in
Albuquerque and Santa Fe, New Mexico. Reference materials that are
widely available in standard text books or reference books need not to
be submitted. Whenever possible, DOE shall submit 10 copies of
reference materials in alternative format (e.g., compact disk) or other
approved format, as specified by the Administrator's authorized
representative.
0
7. Section 194.24 is amended by revising paragraph (c)(3) to read as
follows:
Sec. 194.24 Waste characterization.
* * * * *
(c) * * *
(3) Provide information that demonstrates that the use of
acceptable knowledge to quantify components in waste for disposal
conforms with the quality assurance requirements of Sec. 194.22.
* * * * *
[FR Doc. 04-16207 Filed 7-15-04; 8:45 am]
BILLING CODE 6560-50-P